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Zhang L.,Sun Yat Sen University | Ma S.,Zhejiang Cancer Hospital | Song X.,Guangxi Zhuang Autonomous Region Tumour Hospital | Han B.,Shanghai Chest Hospital | And 11 more authors.
The Lancet Oncology | Year: 2012

Background: Maintenance treatment of patients with advanced non-small-cell lung cancer (NSCLC) without disease progression after first-line chemotherapy is a subject of ongoing research. The aim of the randomised, double-blind, placebo-controlled, INFORM study was to investigate the efficacy, safety, and tolerability of the EGFR-tyrosine-kinase inhibitor gefitinib in the maintenance setting. Methods: Patients were aged 18 years or older, were of east Asian ethnic origin, had a life expectancy of more than 12 weeks, histologically or cytologically confirmed stage IIIb or IV NSCLC, a WHO performance status of 0-2, and had completed four cycles of first-line platinum-based doublet chemotherapy without disease progression or unacceptable toxic effects. Between Sept 28, 2008 and Aug 11, 2009, 296 patients were randomly assigned 1:1 to receive either gefitinib (250 mg per day orally) or placebo (orally) within 3-6 weeks after chemotherapy until progression or unacceptable toxic effects. Randomisation was done via an interactive web response system with computer-generated randomisation codes. Our primary endpoint was progression-free survival assessed in the intention-to-treat population. This completed study is registered with Clinicaltrials.gov, number NCT00770588. Findings: Progression-free survival was significantly longer with gefitinib (n=148) than with placebo (148) (median progression-free survival 4·8 months [95% CI 3·2-8·5] vs 2·6 months [1·6-2·8]; hazard ratio [HR] 0·42, 95% CI 0·33-0·55; p<0·0001). Adverse events occurred more frequently with gefitinib than with placebo; the most common adverse events of any grade were rash (73 [50%] of 147 in the gefitinib group vs 14 [9%] of 148 in the placebo group), diarrhoea (37 [25%] vs 13 [9%]), and alanine aminotransferase increase (31 [21%] vs 12 [8%]). The most commonly reported grade 3 or 4 adverse event was alanine aminotransferase increase (3 [2%] of 147 in the gefitinib group, none of 148 in the placebo group). Ten of 147 (7%) patients given gefitinib and five of 148 (3%) patients given placebo had serious adverse events. Three deaths were thought to be related to treatment with gefitinib: one from interstitial lung disease; one from lung infection; and one from pneumonia. Interpretation: Maintenance treatment with gefitinib significantly prolonged progression-free survival compared with placebo in patients from east Asia with advanced NSCLC who achieved disease control after first-line chemotherapy. Clinicians should consider these data when making decisions about maintenance treatment in such patients. Funding: AstraZeneca. © 2012 Elsevier Ltd. Source


Chen Y.,Sun Yat Sen University | Sun Y.,Sun Yat Sen University | Liang S.-B.,Cancer Center | Zong J.-F.,Fujian Provincial Tumor Hospital | And 9 more authors.
Cancer | Year: 2013

background The objective of this study was to evaluate the long-term survival and late toxicities of concurrent-adjuvant chemotherapy in patients with stage III through IVB nasopharyngeal carcinoma (NPC) from endemic regions of China. methods Patients with stage III to IVB NPC were assigned randomly to receive radiotherapy (RT) alone (the RT group) or RT plus concurrent adjuvant chemotherapy (the CRT group). CRT patients received concurrent cisplatin (40 mg/m2) weekly during RT followed by cisplatin (80 mg/m2) and fluorouracil (800 mg/m2 daily for 5 days) every 4 weeks for 3 cycles. The primary endpoint was overall survival. results In total, 316 patients underwent randomization, with 158 to each group. At a median follow-up of 70 months, the 5-year overall survival rate was 72% for the CRT group and 62% for the RT group (hazard ratio, 0.69; 95% confidence interval, 0.48-0.99; P =.043). Failure-free survival was significantly higher in the CRT group (P =.020). Most late toxicities were similar (33% vs 26%; P =.089), except for cranial neuropathy (P =.042), peripheral neuropathy (P =.041), and ear damage (P =.048), which were significantly increased in the CRT group. conclusions The addition of concurrent adjuvant chemotherapy to RT provides survival benefits to patients with stage III through IVB NPC in endemic regions of China, and it does not increase most late toxicities apart from cranial neuropathy, peripheral neuropathy, and ear damage. © 2013 American Cancer Society. Source


Feng S.,Fujian Normal University | Chen R.,Fujian Normal University | Lin J.,Fujian Normal University | Pan J.,Fujian Provincial Tumor Hospital | And 4 more authors.
Biosensors and Bioelectronics | Year: 2011

We have recently applied surface-enhanced Raman spectroscopy (SERS) for blood plasma analysis for non-invasive nasopharyngeal cancer detection and obtained good preliminary results. The aim of this study was to develop a more robust SERS spectroscopy based blood plasma analysis method for non-invasive gastric cancer detection. The effect of different laser polarizations (non-polarized, linear-polarized, right-handed circularly polarized, and left-handed circularly polarized) on blood plasma SERS spectroscopy was explored for the first time. Silver nanoparticles as the SERS-substrate were directly mixed with blood plasma to enhance the Raman scattering of various biomolecular constituents. High quality SERS spectra were obtained using a fiber optic probe and a dispersive type near infrared Raman system. Blood plasma samples from gastric cancer patients (n= 32) and healthy subjects (n= 33) were analyzed. The diagnostic performance for differentiating gastric cancer plasma from normal plasma was evaluated. Principal component analysis combined with linear discriminant analysis (LDA) of the obtained spectral data was used to develop diagnostic algorithms. Classification results obtained from cross-validation of the LDA model based on the four spectral data sets of different laser polarizations demonstrated different diagnostic sensitivities and specificities: 71.9% and 72.7% for non-polarized laser excitation, 75% and 87.9% for linear-polarized laser excitation, 81.3% and 78.8% for right-handed circularly polarized laser excitation, 100% and 97% for left-handed circularly polarized laser excitation. The results from this exploratory study demonstrated that plasma SERS spectroscopy with left-handed circularly polarized laser excitation has great promise of becoming a clinically useful diagnostic tool for non-invasive gastric cancer detection. © 2010 Elsevier B.V. Source


Ju Z.H.,Fujian Provincial Tumor Hospital
Zhonghua wai ke za zhi [Chinese journal of surgery] | Year: 2010

To study the effect on promoter de-methylation, expression of ALDH1a2 gene and cell apoptosis by treated with 5-Aza-dC and TSA in five human bladder cancer cell lines. Human bladder cancer cell lines RT-4, 253J, 5637, BIU-87 and T24 were cultured and treated with 5-Aza-dC and(or) TSA. The expression of the ALDH1a2 gene was detected by RT-PCR and Western blot. The methylation status of gene promoter was determined by MSP, and the cell cycle profile was established by flow cytometry. ALDH1a2 was silenced in five human bladder cancer cell lines. Re-expression of ALDH1a2 was detected after treated with 5-Aza-dC alone or TSA in combination. ALDH1a2 transcript was marked in each cell lines combined with 5-Aza-dC and TSA treatment which showed a synergistic effect on expression of ALDH1a2 transcript. Early apoptotic was the main mode of apoptosis and death of human bladder cancer cell lines induced by 5-Aza-dC and TSA. The percentage of early apoptotic cells was 1.4% in control group and 2.8% in TSA group, however, 20.2% in 5-Aza-dC group and 33.8% in 5-Aza-dC + TSA group, respectively. The groups of TSA, 5-Aza-dC and 5-Aza-dC + TSA were significantly different from control group (P < 0.05). Aberrant methylation of ALDH1a2 gene is the main cause for gene transcriptional inactivation. Re-expression of ALDH1a2 gene and cell apoptosis are detected after either treatment with 5-Aza-dC alone or in combination with TSA. Source


Yan J.,Fujian Provincial Tumor Hospital
Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery | Year: 2010

To compare the medial-to-lateral approach with the lateral-to-medial approach in laparoscopic right hemi-colectomy for right colon cancer. A prospective randomized controlled trial was performed in the Fujian provincial tumor hospital between January 2007 and July 2009. Forty-eight cases with right colon cancer were randomly divided into two groups:medial-to-lateral laparoscopic right hemi-colectomy group(group M) and lateral-to-medial laparoscopic right hemi-colectomy group(group L). Primary outcome(operative time) and secondary outcomes (estimated blood loss, intra-operative complication, post-operative complication, number of lymph node retrieval, hospital stay) were compared between two groups. Operative time was(122.5+/-25.8) min in group M and (162.9+/-30.9) min in Group L (P=0.01). Estimated blood loss was(55.8+/-36.2) ml in group M and (104.6+/-58.2) ml in group L(P=0.01). There were no significant differences between the two groups in intra-operative complications(4.2% vs 8.3%, P=1.00), post-operative complications (8.3% vs 16.7%, P=0.66), number of lymph node retrieval (17.4+/-3.2 vs 17.8+/-3.4, P=0.67), and hospital stay[(7.8+/-2.2) d vs (8.0+/-3.6) d, P=0.81]. The medial-to-lateral approach reduces operative time and blood loss in laparoscopic right hemi-colectomy as compared with the lateral-to-medial approach. Source

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